The US Food and Drug Administration (FDA) has approved Imjudo (tremelimumab-actl) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

The approval was based on data from the open-label, phase 3 POSEIDON study (ClinicalTrials.gov Identifier: NCT03164616), which was designed to evaluate the efficacy and safety of tremelimumab plus durvalumab and platinum-based chemotherapy in 675 patients with metastatic NSCLC who had not received prior systemic therapy.

Patients were randomly assigned 1:1:1 to receive tremelimumab plus durvalumab and platinum-based chemotherapy; durvalumab plus platinum-based chemotherapy; or platinum-based chemotherapy. The primary endpoints were progression-free survival (PFS) and overall survival (OS).

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Treatment with tremelimumab plus durvalumab and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared with platinum-based chemotherapy (hazard ratio [HR], 0.77; 95% CI, 0.65-0.92; 2-sided P =.00304). The median OS was 14 months and 11.7 months, respectively.

A statistically significant and clinically meaningful improvement in PFS was observed with tremelimumab plus durvalumab and platinum-based chemotherapy compared with platinum-based chemotherapy (HR, 0.72; 95% CI, 0.60-0.86; 2-sided P =.00031). The median PFS was 6.2 months and 4.8 months, respectively.

The most common adverse events reported were nausea, fatigue, decreased appetite, musculoskeletal pain, rash, and diarrhea. The most common grade 3-4 events were neutropenia, anemia, leukopenia, lymphocytopenia, increased lipase, hyponatremia, and thrombocytopenia.

Imjudo is also indicated in combination with Imfinzi for the treatment of adults with unresectable hepatocellular carcinoma.

References

  1. FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer. News release. US Food and Drug Administration. Accessed November 10, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremelimumab-combination-durvalumab-and-platinum-based-chemotherapy-metastatic-non
  2. Imfinzi and Imjudo with chemotherapy approved in the US for patients with metastatic non-small cell lung cancer. News release. November 11, 2022. https://www.businesswire.com/news/home/20221111005248/en/IMFINZI-and-IMJUDO-with-chemotherapy-approved-in-the-US-for-patients-with-metastatic-non-small-cell-lung-cancer
  3. Imjudo. Package insert. AstraZeneca; 2022. Accessed November 10, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf

This article originally appeared on MPR

Topics:

Lung Cancer Non-Small Cell Lung Cancer